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927ZHND - Flavorings Risk Assessment

Principal Investigator (PI)

Primary Goal Addressed

Secondary Goal Addressed

None

Attributed to Manufacturing

100%

Project Description

Short Summary

In response to stakeholder interest (OSHA, Congress, CalOSHA, Flavorings and Extracts Manufacturers' Association) in reports of the respiratory disease, bronchiolitis obliterans, in workers at microwave popcorn and flavoring manufacturers, NIOSH is considering developing authoritative recommendations in the form of a recommended exposure level (REL) and other recommendations regarding engineering controls, work practices, respiratory protection, etc. To support this effort, the Risk Evaluation Branch is conducting a quantitative risk assessment for flavoring components, particularly, diacetyl, which has been implicated as the likely cause of the observed human health effects.

Description

In response to stakeholder interest (OSHA, Congress, CalOSHA, Flavorings and Extracts Manufacturers' Association) in reports of the respiratory disease, bronchiolitis obliterans, in workers at microwave popcorn and flavoring manufacturers, NIOSH is considering developing authoritative recommendations in the form of a recommended exposure level (REL) and other recommendations regarding engineering controls, work practices, respiratory protection, etc. To support this effort, the Risk Evaluation Branch is conducting a quantitative risk assessment for flavoring components, particularly, diacetyl, which has been implicated as the likely cause of the observed human health effects.

The evidence for human health effects from diacetyl exposure comes from Health Hazard Evaluations (HHE's) conducted by the Division of Respiratory Disease Studies. The Risk Evaluation Branch will be analyzing the data from several HHE's to determine the best way to assess the exposure-response relationship of diacetyl in the workplace air and decrease in pulmonary function.

In addition, REB will be evaluating the animal data from studies conducted by the Health Effects Laboratory Division and the National Institute for Environmental Health Sciences. These data will be used to corroborate the dose-response relationship observed in the human data and/or to evaluate mechanistic considerations.

During the conduct of this risk assessment, REB staff will work closely with OSHA staff to coordinate analyses. OSHA will be a full research collaborator in this risk assessment process.

In FY09, the Risk Evaluation Branch expects to obtain complete data sets from DRDS, build a job-exposure matrix and conduct exposure-response analyses appropriate to the human data, combining data sets when appropriate. In addition, dose-response analysis will be conducted on the animal data to inform the human risk assessments. The analyses will be incorporated into the Flavorings document being drafted by the Document Development Branch.

Objectives

The primary objective of this project is to develop health recommendations for diacetyl and disseminate that information in the form of a NIOSH document, which will summarize health effects studies in humans and animals and provide a quantitative risk assessment of diacetyl as a component of flavorings.

Mission Relevance

This project fulfills one of NIOSH's primary missions – the development of recommendations and then dissemination of this information on occupational hazards. A NIOSH document will be developed to summarize the state of the science on adverse health effects and risks to workers exposed to diacetyl as a component of flavorings. This risk assessment and the ensuing authoritative recommendations will also establish a template and lead to insights in how NIOSH might evaluate the many other flavorings compounds in the workplace.

This project contributes to the following sector: Manufacturing (100%)

Goal 5: Reduce the number of respiratory conditions and diseases due to exposures in the manufacturing sector. This project also contributes to the following cross-sectors:

Authoritative Recommendations (100%)

Goal 1: Reduce and prevent occupational injuries, illnesses and fatalities by supporting NORA sector and cross-sector programs in the development of authoritative recommendations.

AG1.3.4 Provide regulators with information needed to address current requests for Emergency Temporary Standards for diacetyl and the data and risk assessments they will need for worker protection over the long term.